Performance of Different Resin Infiltration Materials on White Spot Lesions: Clinical and Laboratory Assessments

The study is a clinical controlled trial. Ethical approval will be obtained from Imam Abdulrahman bin Faisal University, Dammam. The study participants will be recruited from the dental hospital and conducted between November 2020 to November 2020. This will be a single-center, randomized, single blinded with a 1:1:1 allocation ratio for the application of Icon® resin infiltration, MI Paste Plus and both treatments

Study Overview

• Status: Unknown
• Conditions: White Spot Lesion
• Intervention / Treatment: Other: Icon® resin infiltration; Other: MI paste plus

• Study Type: Interventional
• Enrollment (Anticipated): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Dammam, Saudi Arabia, 32437
    • Imam Abdulrahman Bin Faisal University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients who are willing and able to observe good oral hygiene and attend for the study visits.
• Subjects with ≥1 visible and accessible early caries lesion present.
• No prior white spot lesion treatment utilized except tooth brushing with fluoridated toothpaste.

Exclusion Criteria:

• Active carious lesions
• Facial surface restorations
• Deciduous teeth
• Enamel alteration (fluorosis, opacity, hypocalcification, hypoplasia)
• Intrinsic and extrinsic strains
• Physically and mentally challenged volunteers
• Patients with systemic diseases under medication
• Smokers

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 2	Other: MI paste plus; s a superior form of fluoride ions as it also contains CPP-ACP, enhances mineral release without encouraging the formation of calculus.
Experimental: Group 1	Other: Icon® resin infiltration; low viscosity resin that can flow through the pores in the enamel surface
Active Comparator: Group 3	Other: Icon® resin infiltration; low viscosity resin that can flow through the pores in the enamel surface; Other: MI paste plus; s a superior form of fluoride ions as it also contains CPP-ACP, enhances mineral release without encouraging the formation of calculus.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Color improvements	Pre-treatment and post-treatment color changing (L*A*B values) of digital photographs using the Commission Internationale de l'Eclairage (CIE) system	Change from 0 day, 1 month and 6 months
Patient self satisfaction	Post-treatment patient satisfaction using the patient satisfaction scale	Change from 0 day, 1 month and 6 months
Change in lesion status	Post-treatment change in caries lesion status using ICDAS II	Change from 0 day, 1 month and 6 months
Cracks of enamel.	Number of cracks assessed by enamel surface analysis via silicone replicas using CLSM	Change from 0 day, 1 month and 6 months
Microbial composition.	Pre-treatment and post-treatment microbial composition of plaque samples. Samples will be stored at -80 °C until DNA extractions will be performed and run the 16S rRNA sequencing.	Change from 0 day, 1 month and 6 months
Effects on clinical parameter: sensitivity to percussion	Pre-treatment and post-treatment effects on sensitivity to percussion by end blunted instrument.	Change from 0 day, 1 month and 6 months
esthetic improvement	Esthetic improvement through objective assessments using a visual analogue	Change from 0 day, 1 month and 6 months
Patient esthetic self perception	Pre-treatment esthetic self perception by the subjects using questionnaire	Change from 0 day, 1 month and 6 months
change in lesion size	Pre-treatment and post-treatment white spot lesion size	Change from 0 day, 1 month and 6 months
fracture of enamel.	Number of fracture assessed by enamel surface analysis via silicone replicas using CLSM	Change from 0 day, 1 month and 6 months
Effects on clinical parameter: prolonged response to hot or cold.	Pre-treatment and post-treatment effects on response to hot or cold by cold test	Change from 0 day, 1 month and 6 months

Collaborators and Investigators

• Sponsor: Imam Abdulrahman Bin Faisal University

Study record dates

Study Major Dates

• Study Start (Anticipated): December 19, 2020
• Primary Completion (Anticipated): November 30, 2022
• Study Completion (Anticipated): November 30, 2022

Study Registration Dates

• First Submitted: October 10, 2020
• First Submitted That Met QC Criteria: December 12, 2020
• First Posted (Actual): December 17, 2020

Study Record Updates

• Last Update Posted (Actual): December 17, 2020
• Last Update Submitted That Met QC Criteria: December 12, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: IAU_resin

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No